JP2011530326A - Vascular occlusion device with textured surface - Google Patents

Abstract

A vascular occlusion device including a textured outer surface or a method of making and using such a device.
A vaso-occlusion device for forming an occlusion in a patient's vasculature having a textured outer surface for promoting tissue ingrowth.
[Selection] Figure 1

Description

  Compositions and methods for aneurysm repair are described. In particular, vaso-occlusive devices having non-random textured outer surfaces are disclosed as well as how to make and use these devices.

  An aneurysm is an expansion of a blood vessel that poses a health risk from the possibility of rupture, coagulation, or incision. An aneurysm rupture in the brain causes a stroke, and an aneurysm rupture in the abdomen causes a shock. Cerebral aneurysms are usually detected in patients as a result of stroke or bleeding and can result in significant morbidity or mortality.

  There are a variety of materials and devices that have been used for the treatment of aneurysms, including platinum and stainless steel microcoils, polyvinyl alcohol sponge (Ivalone), and other mechanical devices. For example, a vaso-occlusive device is typically placed through the catheter into the vasculature of the human body, blocking the blood flow through the blood vessels that make up that portion of the vasculature by the formation of emboli, or in an aneurysm arising from the blood vessels. A surgical tool or implant that forms such an embolus. One widely used vaso-occlusive device is a spiral wire coil having a winding that can be dimensioned to engage a vessel wall (eg, US Pat. No. 4, granted to Ritchart et al. , 994,069). An electrolytically detachable embolization device has also been described (US Pat. No. 5,354,295 and its parent US Pat. No. 5,122,136) but has few inherent secondary shapes. Also described are vaso-occlusive coils with or without (see, for example, commonly owned US Pat. Nos. 5,690,666, 5,826,587, and 6,458,119). In addition, multi-reference microcoils are described in US Pat. No. 6,159,165.

  A coil design is also described that includes a stretch resistant member that passes through the lumen of the helical vaso-occlusive coil. For example, U.S. Pat. Nos. 5,582,619, 5,833,705, 5,853,418, 6,004,338, 6,013,084, 6,179,857. No. and 6,193,728.

  In addition, coil devices that include polymer coatings or attached polymer filaments are also described. For example, U.S. Pat. Nos. 5,658,308, 5,792,154, 5,935,145, 6,0011,092, 6,033,423, 6,280,457. No. 6,287,318 and 6,299,627. For example, US Pat. No. 6,280,457 describes a wire vaso-occlusive coil having a single or multifilament polymer coating. US Pat. Nos. 6,287,318 and 5,935,145 describe a metal vaso-occlusion device having a braided polymer component attached to the metal vaso-occlusion device. U.S. Pat. No. 5,382,259 describes a braid covering the primary coil structure.

US Pat. No. 4,994,069 US Pat. No. 5,354,295 US Pat. No. 5,122,136 US Pat. No. 5,690,666 US Pat. No. 5,826,587 US Pat. No. 6,458,119 US Pat. No. 6,159,165 US Pat. No. 5,582,619 US Pat. No. 5,833,705 US Pat. No. 5,853,418 US Pat. No. 6,004,338 US Pat. No. 6,013,084 US Pat. No. 6,179,857 US Pat. No. 6,193,728 US Pat. No. 5,658,308 US Pat. No. 5,792,154 US Pat. No. 5,935,145 US Pat. No. 6,0011,092 US Pat. No. 6,033,423 US Pat. No. 6,280,457 US Pat. No. 6,287,318 US Pat. No. 6,299,627 US Pat. No. 5,382,259 US Pat. No. 6,953,468 US Pat. No. 3,174,851 U.S. Pat. No. 3,351,463 US Pat. No. 3,753,700 US Pat. No. 6,635,069 US Pat. No. 6,929,654 US Pat. No. 6,168,788 US Pat. No. 5,290,552 US Pat. No. 6,585,754 WO 02/051460 U.S. Pat. No. 4,739,768 US Pat. No. 6,623,493 US Pat. No. 6,533,801 WO 02/45596

  However, there remains a need for vaso-occlusive devices that include a textured outer surface as described herein, or methods of making and using such devices.

  Accordingly, the present invention includes new occlusion devices and methods of using and making these devices.

  In one aspect, described herein is a vaso-occlusive device having an outer surface that includes a non-random texture that includes a raised region and a recessed region, wherein the raised region is around at least a portion of such outer surface. Arranged in a repetitive manner and separated from at least one adjacent raised region by an average axial distance and an average radial distance. In certain embodiments, the vaso-occlusive device further includes a core wire.

  In another aspect, provided herein is a vascular occlusion device having a non-random textured outer surface, the device comprising a core wire formed in a primary configuration, wherein the core wire comprises at least a portion of the outer surface of the device. Form.

  In any of the devices described herein, the core wire can be textured and / or one or more filaments can be wrapped around the core wire (eg, one or more). The core wire or device so that there is a gap between the filament and the core wire).

  Any of the devices described herein (eg, core wires and / or filaments) can include metals (eg, gold, nickel, titanium, tantalum, platinum, and alloys or combinations thereof). In certain embodiments, the one or more filaments and / or core wires are platinum.

  In certain embodiments, a vaso-occlusive device as described herein is a helical coil shape. Further, any of the devices can have a secondary shape that self-forms upon deployment, eg, a secondary shape that includes a plurality of connecting loop segments, each segment being in a different plane than the adjacent segment, Leaf shape, spiral shape, figure eight shape, flower shape, vortex shape, egg shape, random shape, and substantially spherical shape.

  Any of the devices described herein may be detached joints (eg, electrolytically detachable joints or detachables that can be detached by mechanical, hydraulic, electrical, electromagnetic, thermal, or sonic means). A separable joint). The detachment junction can be located anywhere on the device, for example, at one or both ends of the device. In certain embodiments, the separable junction is an electrically detachable assembly that is decoupled by the application of electrical current, a mechanical decoupling that is decoupled by movement or pressure. Releasable assemblies, thermally releasable assemblies that are desorbed by the local delivery of heat to the joint, and radiations that are desorbed by the delivery of electromagnetic radiation to the joint Or a combination thereof.

  Further, any of the devices described herein can further include one or more additional components, such as bioactive components.

  In another aspect, provided herein is a method for at least partially occluding an aneurysm, the method comprising introducing a vaso-occlusive device as described herein into the aneurysm. .

  In yet another aspect, described herein is a method of making a vaso-occlusive device as described herein, wherein the method wraps a textured core wire into a primary helical shape, thereby creating a texture. Making a vaso-occlusive device having an outer surface.

  In yet another aspect, provided herein is a method of making a vaso-occlusion device as described herein, wherein the method places one or more filaments around a core wire. Winding a core wire having one or more wound filaments around a mandrel to form a microcoil, wherein at least a portion of the filaments comprises a portion of the outer surface of the device. Formed and wound in an open pitch configuration to create a vaso-occlusive device having a textured outer surface.

  In yet another aspect, provided herein is a method of making a vaso-occlusive device comprising a core wire and one or more filaments, wherein there is a gap between the core wire and at least one of the filaments. The method comprises the steps of providing a core wire at least partially coated with one or more dissolvable, degradable, or shrinkable materials; and one or more filaments of the core wire; Winding around and dissolving, degrading or shrinking the degradable or shrinkable material, thereby creating a vaso-occlusive device having a gap between one or more filaments and the core wire. In certain embodiments, the material decomposes upon application of heat.

  In another aspect, the invention includes a method of occluding a body cavity comprising introducing any of the vascular occlusion devices described herein into a body cavity (eg, an aneurysm). In certain embodiments, the devices described herein can be packaged within a selected target site (eg, an aneurysm).

  These and other embodiments of the present invention will readily occur to those skilled in the art in light of the disclosure herein.

FIG. 6 shows a side view of an exemplary filament-coated wire showing evenly spaced filament coatings. FIG. 3 shows a side view of an exemplary filament-coated wire showing the filament-coated wire in contact with some windings of the filament. FIG. 3 shows a side view of an exemplary filament-coated wire where the filament itself includes a cable wound filament and the filament is wound around the wire at an irregular pitch and in different (s and z) directions. FIG. 6 shows a side view of an exemplary device having a textured surface as described herein in an embodiment in which the core wire is wrapped with one or more filaments at an open, regularly spaced pitch. FIG. 6 shows an axial cross section of an exemplary device having a textured surface as described herein in which the core wire is wrapped with two filaments and the wrap core wire is wound into a helical coil. 3C shows an overview of the exemplary device depicted in FIG. 3B having a textured surface as described herein. FIG. FIG. 5 is a side view of an exemplary embodiment of another exemplary device having a textured surface as described herein, wherein the wire wound on the spiral wound coil is a patterned wire. FIG. 4B is an axial cross-sectional view of the embodiment shown in FIG. 4A of another exemplary apparatus having a textured surface as described herein. Another having a textured surface as described herein comprising a wire wrapped with an open, regularly spaced pitch with one or more filaments such that at least some of the filaments do not contact the core wire FIG. 2 is a side view of the exemplary apparatus of FIG. FIG. 6 is an axial cross-sectional view of another exemplary apparatus having a textured surface as described herein. FIG. 2 is an overview of a non-textured device showing a coil device without texture processing; It is a fragmentary sectional view of the random texture apparatus which shows the coil apparatus which has a random texture process. 1 is an overview of an exemplary non-random texture occlusion device as described herein. FIG. 1 is an overview of an exemplary non-random texture occlusion device as described herein. FIG. 1 is an overview of an exemplary non-random texture occlusion device as described herein. FIG. 1 is an overview of an exemplary non-random texture occlusion device as described herein. FIG. 1 is an overview of an exemplary non-random texture occlusion device as described herein. FIG. 1 is an overview of an exemplary non-random texture occlusion device as described herein. FIG. FIG. 6 is an overview and partial cross-sectional view of another exemplary device having a non-random textured outer surface.

  An occlusion (eg, embolization) device will be described. The devices described herein find use in vascular and neurovascular indications and are difficult to access, for example, small diameter curved or other vasculature, eg, aneurysms such as cerebral aneurysms It is particularly useful for treating complex aneurysms. The methods of making and using these vaso-occlusive devices also form an aspect of the present invention. The compositions and methods described herein provide better occlusion and treatment results than known devices, for example, because textured surfaces promote tissue ingrowth and increased surface area results in greater tissue reactivity. (Eg, long-term durability) and / or surface patterning can also create a more durable clot (eg, a clot that is less susceptible to disruption of fibrinolysis). Can cause blood flow disturbances that may promote Furthermore, devices having modified textures disposed on the outer surface as described herein above are relatively low compared to conventional methods of surface texturing such as polishing, porous coating, and multifilament coating. There is a tendency to have a friction surface.

  Accordingly, the advantages of the present invention include, but are not limited to, (i) the provision of a low friction vascular occlusion device, (ii) the provision of an occlusion device that can be packed into an aneurysm at high density, (iii) Occlusion device with improved exposure of the surface of the component to the blood flow; (iv) occlusion device that does not supplement or interact adversely with the delivery catheter; (vi) removed and / or after deployment. Including the provision of occluding devices that can be repositioned, and (vii) cost-effective generation of these devices.

  All documents, patents, and patent applications above or below cited herein are hereby incorporated by reference in their entirety.

  Note that as used in this specification and claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. Should. Thus, for example, reference to a device containing “a filament” includes a device comprised of two or more filaments.

  The vaso-occlusive device described herein has a three-dimensional textured surface. Preferably, the texture outer surface has a non-random texture. “Non-random” includes any ordered or semi-ordered structure with a texture on the outer surface. For example, a non-random textured surface can include raised areas and recessed areas that are arranged in an iterative fashion around the outer surface and separated from adjacent raised elements by an average distance. Thus, unlike random texture devices such as sandblasting devices (see US Pat. No. 6,953,468), the devices described herein have a non-random texture on the outer surface.

  In order to produce a surface texture that can provide maximum biological contact and maintain low friction, the pattern is preferably considered to include recessed areas in the form of gaps, grooves, valleys, or voids; The minimum regular (repeated) distance between the raised areas is less than the smallest regular (repeated) dimension of the raised areas. Preferably, the minimum regular (repeated) distance between raised areas is considered to be in the 2-100 micron range, more preferably 10-40 microns.

  The textured surface was already formed by delineating or patterning the wire and forming a vaso-occlusive device so that the outer surface of the device is formed by both the outer surface of the core wire and the outer surface of the filament It can be created by delineating or patterning the vaso-occlusive device and / or by placing one or more filaments around the outer surface of the core wire. By “filament” is meant any long thin structure having a small cross-section. Thus, as used herein, the term includes monofilaments as well as multifilaments (eg, multifilament yarns, sewing threads, or sutures), and any cross-sectional profile (circular, oval, triangular, rectangular, etc. And a filament having Furthermore, the filament itself can be a multifilament wound, for example a cable wound (s or z wound) filament. The filaments can be wound at regular or irregular pitches and in any direction (S or Z winding). Furthermore, some turns may not include a gap between them (FIG. 1).

  When present, the core wire, device, and optional filament can be made of any material including, but not limited to, metals and / or polymers (see below). In certain embodiments, the device is “metallic” in that the device is composed solely of metal (or metal alloy) and does not include any polymer. Non-limiting examples of metals are all biologically compatible such as “platinum group” metals, especially platinum, rhodium, palladium, rhenium, and tungsten, gold, silver, tantalum, and alloys of these metals. Includes metals or metal alloys. Suitable “superelastic alloys” include nickel / titanium alloys (48-58 atomic% nickel and optionally containing moderate amounts of iron), copper / zinc alloys (38-42 wt% zinc), beryllium, A copper / zinc alloy containing 1-10% by weight of silicon, tin, aluminum, or gallium, or a nickel / aluminum alloy (36-38 atomic% aluminum). See, for example, U.S. Pat. Nos. 3,174,851, 3,351,463, and 3,753,700. Particularly preferred is a titanium / nickel alloy known as Nitinol®. There are very strong alloys that will withstand significant bending without deformation, even when used as very small diameter filaments. In a preferred embodiment, the metal wire (patterned or filament coating) is wound into a primary spiral shape. The wire can be subjected to a heating step, although not necessarily, to set the wire to the primary shape.

  The diameter of the wire is often in the range of 0.0005 to 0.050 inches in diameter, preferably about 0.001 to about 0.004 inches. Similarly, the filament diameter is typically in the range of 0.0003 to 0.005 inches, more preferably. From 0,050. 00007 inches. Preferably, the filament diameter is equal to or greater than the diameter of the gap (pitch) created when the filament is wound around the core wire. Determination of appropriate filament diameter, pitch (interval between turns) and / or filament coating (z and / or s) and primary wire turns (Z and S) is within the skill of the skilled artisan. .

  The core wire itself can have a uniform cross section, or alternatively it can have a non-uniform cross section due to a textured surface (FIG. 4). By “texturing” or “patterning”, any core wire having a non-uniform cross-section, for example, depressions (regular or irregular), rough portions, patterns therein that result in a wire having a textured outer surface Or a wire with any other modification.

  Further, with respect to the entire device, the overall cross-section of the device described herein is not uniform or constant. See, for example, FIGS. 3B, 4B, and 5B. For example, in the embodiment shown in FIGS. 3B and 5B, both wire and filament surfaces are exposed when the device is incorporated into the vasculature. Similarly, the non-uniform surface of the recessed (patterned) wire shown in FIGS. 4A and 4B also creates a textured surface when the wire is wound into a primary helical coil configuration. The textured outer surface of the device promotes tissue ingrowth and / or reduces friction.

  When present, the filaments are core wire in one or more locations, for example, by heating or by using an adhesive (eg, EVA) to the filament or to the core wire, or by other suitable means. Can be glued to. The filament can be fixed at multiple locations on the core wire, for example, at one or both ends. Alternatively, the filament cannot be secured (attached) to the underlying core wire. In yet other embodiments, the layer of degradable polymer is positioned between the filament and the core wire.

  In certain embodiments, the device changes shape (configuration) when deployed, eg, from a constrained linear form to a loose three-dimensional (secondary) configuration. See also US Pat. No. 6,280,457. Methods of making metallic and / or polymer vaso-occlusive coils having a linear helical shape and / or different three-dimensional (secondary) configurations are known in the art and are described in the documents cited above, for example, US Pat. This is described in detail in US Pat. No. 6,280,457. Thus, as a whole, the vaso-occlusive device or element thereof has a secondary shape or structure that is different from the linear coil shape shown in the figure, for example, overlapping or non-overlapping spherical, elliptical, helical, oval, 8-shaped, etc It is further within the scope of the present invention. See, for example, US Pat. Nos. 6,635,069 and 6,929,654. The devices described herein can be self-forming in that they have a secondary configuration when deployed into an aneurysm. Alternatively, the device can have these secondary configurations under certain conditions (eg, temperature change, energy application, etc.).

  In addition, a stretch resistant configuration can also be designed and manufactured. For example, the fibrous material can pass through the inside of the device and be secured to both the proximal and distal ends of the device. See U.S. Patent No. 6,280,457.

  Further, it will be apparent that the core wire can be wound into a primary (linear) and / or secondary configuration (eg, a pre-formed filament structure or filament winding) before and after combining the core wire with the filament. For example, the filament can be added to an already shaped core wire, for example by loading the filament onto an underlying core wire wound into a helical coil, and the filament is in one or more positions Fixing to the underlying molded core wire (eg, using UV curable adhesive and optionally thermosetting to fix the ends of the filament structure, the device can be overlaid (eg, coiled ) Shrink the filament structure against the wire). Thus, winding, braiding, weaving, etc. can be performed in the absence of a core wire, after which the already constructed filament structure can be combined with the core wire. Non-limiting examples of such filament structures include braids, woven structures, tubular configurations, non-woven materials (eg, felt-like materials), and the like. Such preformed filament structures can be attached in any manner to the core wire in one or more locations. For example, in certain embodiments, the preformed filament structure is attached to the core wire by its end (eg, to the end of the core wire).

  FIG. 1 shows a filament 50 wound around the core wire 10. As shown in FIG. 1A, the filaments can be regularly spaced, or, as in FIG. 1B, some of the windings of the filament 50 can be such that at least a portion of the core wire 10 is formed when the device is formed. As long as they form part of the outer surface of the entire device, they can be adjacent.

  FIG. 2 shows a cable winding filament 50 wound around the core wire 10. As shown in this figure, the filament 50 windings can be irregular, for example, some windings can be adjacent and some can be separated. In addition, FIG. 2 shows how the filament 50 can be wound in different directions along the length of the wire.

  FIG. 3A shows an embodiment in which the filament 50 is spirally wound around the core wire 10. The filament and core wire are preferably metal, such as platinum. The filament 50 is wound around the core wire 10 in such a way that when the filament-coated wire is formed in a primary helical configuration, at least a portion of the core wire 10 forms part of the outer surface of the device. Further, although the filament shown in FIG. 3 is wound at regular pitch intervals, it will also be apparent that irregular pitch windings are contemplated. FIG. 3B shows an axial cross-section of the device shown in FIG. 3A, showing that the spiral wound element and device have a non-uniform cross-section that generally results in a textured outer surface. FIG. 3C is an overview showing a filament-coated wire wound around a helical coil, showing a raised region 40 and a recessed region 60 created by winding two filaments 50, 55 around the core wire 10. A single filament or two or more filaments (eg, three or more) can also be wound around the core wire.

  FIG. 4A shows an apparatus in which the patterned core wire 10 is formed into a helically wound coil. In a preferred embodiment, the core wire is, for example, platinum. The illustrated embodiment shows a regular patterning (indentation) profile. Irregular patterning profiles are also considered. The axial cross section of the device as shown in FIG. 4B is irregular, resulting in a device having a textured outer surface.

  FIG. 5A shows a device with a gap between the filament 15 and the core wire 10. The distance between the filament 15 and the core wire 10 can be constant or can vary along the length of the device. For example, in one or more regions, the filament 15 can contact the core wire.

  Devices that include at least some space between the filament and the core wire (see, eg, FIG. 5A) can be made in a variety of ways. For example, in certain embodiments, the metallic core wire is coated with a dissolvable, degradable, or shrinkable material (eg, a polymer). Thereafter, the metallic filament is wound around the coated core wire. When the resulting device is subjected to conditions that dissolve, degrade, or shrink the coating material, the coating material is eliminated or reduced to leave a space between the core wire and the filament. Non-limiting examples of conditions that dissolve, decompose, or shrink the coating material include exposure to heat (thermal energy), exposure to a solvent that degrades or shrinks the coating material, and the like. In other embodiments, the filament can be wound around the core wire so that at least certain areas of the filament do not contact the wire (the wire is wound into a primary configuration of the wire, such as a spiral wound coil). Back and forth).

  Non-limiting examples of synthetic and natural polymers that are soluble, degradable, or shrinkable include polyurethanes (including block copolymers with soft segments containing esters, ethers, and carbonates), polyethers, polyamides (nylon polymers). And polyimide derivatives (including both thermosetting and thermoplastic materials), acrylates (including cyanoacrylates), epoxy adhesives (two-component or one-component epoxyamine materials), olefins (ethylene, propylene) , Butadiene, styrene, and thermoplastic olefin elastomer polymers and copolymers), fluoropolymers (including polytetrafluoroethylene (ePTFE or PTFE)), polyethylene terephthalate (PET), polydimethylsiloxane systems Polyesters such as limers, crosslinked polymers, non-crosslinked polymers, “rayon”, cellulose, cellulose derivatives such as nitrocellulose, natural rubber, lactide, glycolide, trimethylene carbonate, caprolactone polymers and copolymers thereof, hydroxybutyrate and poly Hydroxyvaleric acid and copolymers thereof, polyether esters such as polydioxynone, anhydrides such as polymers and copolymers of sebacic acid, hexadecanedioic acid and other dibasic acids, or orthoesters.

  The polymer component can include one or more absorbent (biodegradable) polymers and / or one or more non-absorbable polymers. The terms “absorbable” and “biodegradable” can no longer be identified at the site of application in time as the drug is infused, eg, degradation, metabolism, dissolution, or any passive or active removal. Used interchangeably to mean any drug removed through the procedure. Non-limiting examples of absorbable proteins include synthetic and polysaccharide biodegradable hydrogels, collagen, elastin, fibrinogen, fibronectin, vitronectin, laminin, and gelatin. Many of these materials are available for purchase. Fibrin-containing compositions can be purchased from, for example, Baxter. Collagen-containing compositions can be purchased, for example, from Cohesion Technology Inc. of Palo Alto, California, USA. Fibrinogen-containing compositions are described, for example, in US Pat. Nos. 6,168,788 and 5,290,552. Mixtures, copolymers of these materials (both block and random) are also suitable. Furthermore, it will be apparent that the combination of metal and one or more polymer components can be used in any manner, such as coated metal, coated polymer, and the like. The coating preferably leaves the underlying surface pattern intact or reverses to the surface pattern after development.

  FIG. 6A shows a coil device that is untextured or very textured. Coil turns 25 create a single raised spiral region on the outer surface of the device. This configuration is known in the art and is similar to most bare metal embolic coils currently used in clinical practice. It should be noted that this configuration has only one raised area and therefore does not have a repeating pattern of individual raised areas and is therefore distinctly different from the repeated texture claimed herein.

  FIG. 6B shows the apparatus of FIG. 6A with the outer surface 30 randomly textured. It will be apparent that the outer surface can have a random texture overlay on a simple coil device, for example by spraying sand on the coil device as shown in FIG. 6A. The device shown in FIG. 6B can also be formed from a random textured material and then rolled to form the device. This random texture configuration therefore does not possess a non-random repeating pattern of individual raised areas, even if clearly different from the repeating texture claimed herein.

  7A-7F show various devices having a non-random textured outer surface with raised areas 40 and recessed areas 60 on the outer surface of the device. FIG. 8 shows another exemplary non-random texture device, such that the raised region is separated from one or more adjacent raised elements by an average axial distance and an average radial distance 70. It also shows how the raised areas are arranged in a repetitive manner around the outer surface of the device. As shown in FIGS. 7 and 8, the raised areas can be separated from one, two, or more of the adjacent raised areas by an average distance. For example, as shown in FIGS. 7A to 7F, the spacing of the raised areas is relatively uniform compared to all adjacent raised areas (in all directions). FIG. 8 shows that any given ridge region can be seen from a ridge region that is obliquely adjacent by an average distance that is different from the ridge region that is laterally separated (eg, in a “row” of the same cross section) from the adjacent ridge region. An example of separation is shown.

  Any of the devices described herein can be coated using any suitable method during production or co-solvents, plasticizers, radiopaque materials (eg, tantalum, Additional components (such as gold or platinum), coalescent solvents, bioactive agents, antibacterial agents, antithrombotic agents, antibiotics, pigments, radiation opacifiers, and / or ionic conductors (more details below) Can be included). Furthermore, a lubricious (eg, hydrophilic) material can be used to coat one or more members of the device that help to deliver. Certain embolic materials, such as cyanoacrylate resins (especially n-butyl cyanoacrylate), fine particles of polyvinyl alcohol foam, can also be introduced into the intended site after the device of the present invention is in place.

The term “biological activity” refers to any agent that has an effect in vitro, such as a thrombotic agent, an antithrombotic agent (eg, a water-soluble agent that inhibits thrombus for a limited period of time as described above), a therapeutic agent (eg, chemotherapy). Agent). See, for example, commonly owned US Pat. No. 6,585,754 and WO 02/051460. Non-limiting examples of biologically active materials include cytokines, extracellular matrix molecules (eg, collagen), trace metals (eg, copper), and other molecules that stabilize thrombus formation or inhibit clot lysis (eg, , Proteins, or functional fragments of proteins, including, but not limited to, Factor XIII, α ₂ antiplasmin, plasminogen activation factor inhibitor-1 and the like. Non-limiting examples of cytokines that can be used alone or in combination in the practice of the present invention include basic fibroblast growth factor (bFGF), platelet derived growth factor (PDGF), vascular endothelial growth factor (VEGF), Transformation growth factor β (TGF-β) and the like are included. Cytokines, extracellular matrix molecules, and thrombus stabilizing molecules (eg, Factor XIII, PAI-1, etc.) are described in, for example, Genzyme (Framingham, Mass., USA), Genentech (South San Francisco, Calif., USA), Amgen ( Thousand Oaks, California, USA) and R & D Systems and Immunex (Seattle, Washington, USA). In addition, biologically active polypeptides can be synthesized recombinantly since many sequences of these molecules are also available, for example from the Genbank database. Accordingly, the present invention is intended to include the use of DNA or RNA that encodes any biologically active molecule. Cells (eg, fibroblasts, stem cells, etc.) can also be included. Such cells can be genetically modified. In addition, wild-type or purified cytokines, extracellular matrix molecules and thrombus stabilizing proteins (eg, recombinantly produced or mutants thereof) and nucleic acids that encode these molecules, although not always clearly indicated Molecules with similar biological activity are intended for use within the spirit and scope of the present invention. Further, the amount and concentration of liquid embolic material and / or other biologically active materials useful in the practice of the present invention can be readily determined by a skilled operator, and any combination of material, concentration, or dose can be combined. It will be appreciated that can be used as long as it is not harmful to the subject.

  The devices described herein are often introduced at selected sites using the procedure outlined below. This procedure can be used to treat various diseases. For example, in the treatment of an aneurysm, the aneurysm itself will be filled (partially or completely) with the composition described herein.

  Conventional catheter insertion and manipulation techniques including guidewires or flow-guided devices can be used to access the site with a catheter. This mechanism is such that it can be fully advanced through the catheter, and a delivery mechanism that still projects from the distal end of the catheter to the target site to allow removal of the implantable vaso-occlusive device. The vaso-occlusive device will be placed including a sufficient portion of the distal end. For use in peripheral or nerve surgery, the delivery mechanism is typically about 100-200 cm in length, and more typically 130-180 cm in length. The delivery mechanism diameter is typically in the range of 0.25 to about 0.90 mm. Briefly, the occlusion devices (and / or additional components) described herein are typically loaded into a carrier for introduction into a delivery catheter using the procedure outlined below. To be introduced at the selected site. This procedure can be used in the treatment of various diseases. For example, in the treatment of aneurysms, the aneurysm itself can be filled with emboli (eg, vascular occlusion members and / or liquid emboli and bioactive materials) that cause the formation of emboli, and after a while It is at least partially replaced by surrounding angiogenic collagen material.

  The selected site is reached by the vasculature using a specifically selected collection of catheters and / or guide wires. Obviously, if the site is in a remote site, such as the brain, the method of reaching this site is somewhat limited. One widely accepted procedure is found in US Pat. No. 4,994,069 to Ritchart et al. It utilizes a thin intravascular catheter such as that found in US Pat. No. 4,739,768 to Engelson. First, a large catheter is introduced through the entry site of the vasculature. Typically this is thought to pass through the femoral artery in the groin. Other invasion sites that are optionally selected are found in the neck and are known by physicians practicing this type of medical treatment. With the introducer in place, a guide catheter is then used to provide a safe passage from the entry site to the area near the site to be treated. For example, a guide catheter may be selected to treat a region of the human brain, which extends around the heart through the aortic arch between large arteries extending from the entry site in the femoral artery to the heart. It will extend downstream through one of the arteries extending from the top of the aorta. A guide wire and neurovascular catheter as described in the Engelson patent are then placed through the guide catheter. The catheter is removed with the distal end of the catheter positioned at the site by positioning the distal end of the catheter, often using radiopaque marker material and fluoroscopy. For example, if a guidewire is being used to position the catheter, the guidewire is withdrawn from the catheter and then an assembly including, for example, an absorbable vaso-occlusive device at the distal end is advanced through the catheter. .

  Once the selected site has been reached, the vaso-occlusive device is pushed out, for example by loading it onto the pusher wire. Preferably, the vaso-occlusive device is a mechanically or electrolytically cleavable bond (eg, a GDC-type bond that can be cut by application of heat, electrolysis, electrodynamic activation, or other means). Through the push wire. In addition, the vaso-occlusion device has a plurality of detachment points as described above in commonly owned US Pat. Nos. 6,623,493 and 6,533,801, and International Patent Publication WO 02/45596. Can be designed to include. They are held in place by gravity, shape, size, volume, magnetic field, or combinations thereof.

  It will also be apparent that the operator can remove or reposition the device (distal or proximal). For example, the operator can choose to insert the device as described herein above, and can move the pushwire to place the device in the desired location prior to installation.

  Modifications of the above procedures and vaso-occlusive devices and methods of using them with the present invention will be apparent to those skilled in the mechanical and surgical arts. These variations are intended to be within the scope of the following claims.

10 Core wire 50 Filament

Claims (19)

Having an outer surface comprising a non-random texture including raised and recessed regions, the raised region being arranged in a repetitive manner around at least a portion of such outer surface, and only by an average axial distance and an average radial distance Separated from at least one adjacent raised region;
A vaso-occlusive device.   The vascular occlusion device according to claim 1, further comprising a core wire. The core wire is formed in a primary configuration, and the core wire forms at least a portion of the outer surface of the device;
The vascular occlusion device according to claim 2.   The vascular occlusion device according to claim 2 or 3, wherein the core wire is textured.   4. A vaso-occlusive device according to claim 2 or claim 3, further comprising one or more filaments wrapped around the core wire.   6. The vaso-occlusive device of claim 5, wherein the one or more filaments are in contact with the core wire.   6. The vaso-occlusive device of claim 5, wherein a gap exists between the one or more filaments and the core wire.   The vascular occlusion device according to any one of claims 1 to 7, comprising a metal selected from the group consisting of gold, nickel, titanium, tantalum, platinum, and alloys thereof.   9. A device according to any one of claims 5 to 8, wherein the one or more filaments are platinum and / or the core wire is platinum.   The vascular occlusion device according to any one of claims 1 to 9, wherein the vascular occlusion device is a spiral coil.   The vascular occlusion device according to any one of claims 1 to 10, wherein the vascular occlusion device has a secondary shape that self-forms when deployed. The secondary shape is selected from the group consisting of secondary shapes including a plurality of connecting loop segments;
Each segment is in a different plane than the adjacent segment and is clover leaf-shaped, spiral-shaped, 8-shaped, flower-shaped, vortex-shaped, egg-shaped, random-shaped, and substantially spherical.
The vascular occlusion apparatus according to claim 11.   The vaso-occlusive device according to any one of claims 1 to 12, further comprising a desorption joint.   14. The vaso-occlusive device of claim 13, wherein the detachable joint is detachable by mechanical, hydraulic, electrical, electromagnetic, thermal, or sonic means. A method of at least partially blocking an aneurysm,
Introducing the vaso-occlusive device according to any one of claims 1 to 14 into an aneurysm;
A method comprising the steps of: A method of making a vaso-occlusive device according to claim 3,
Winding a textured core wire into a primary helical shape thereby creating a vaso-occlusive device having a textured outer surface;
A method comprising the steps of: A method of making a vaso-occlusive device according to claim 5,
Winding one or more filaments around the core wire;
Winding said core wire having one or more wound filaments around a mandrel to form a microcoil;
Including
At least a portion of the filament is wound in an open pitch configuration such that the core wire forms a portion of the outer surface of the vaso-occlusive device, thereby creating a vaso-occlusive device having a textured outer surface;
A method characterized by that. A method of making a vaso-occlusive device according to claim 7,
Providing a core wire at least partially coated with one or more dissolvable, degradable, or shrinkable materials;
Winding one or more filaments around the core wire;
Dissolving, degrading or shrinking the degradable or shrinkable material, thereby creating a vaso-occlusive device having a gap between the one or more filaments and the core wire;
A method comprising the steps of:   19. The method of claim 18, wherein the material is decomposed upon application of heat, or the material is dissolved by a solvent.

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